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NCT Number: NCT07607080

Predicting High-Flow Nasal Cannula Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data

The goal of this observational study is to determine whether metabolomic profiles combined with clinical data can predict high-flow nasal cannula (HFNC) failure and help optimize respiratory support in adult patients with acute hypoxemic respiratory failure (AHRF). The main questions it aims to answer are:

Can metabolomic biomarkers identify patients at higher risk of HFNC failure? Does combining metabolomic and clinical data improve the prediction of respiratory support escalation and clinical outcomes?

Participants will:

Receive standard HFNC treatment according to clinical practice. Undergo collection of clinical, physiological, and laboratory data. Provide blood samples for metabolomic analysis during respiratory support.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This observational study aims to evaluate whether metabolomic signatures combined with routinely collected clinical and physiological data can improve the prediction of high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF). HFNC is widely used as first-line non-invasive respiratory support in AHRF; however, delayed recognition of treatment failure may lead to worse clinical outcomes, including delayed intubation and increased morbidity and mortality.

The study will prospectively enroll adult patients with AHRF treated with HFNC. Clinical variables, respiratory parameters, laboratory results, and patient outcomes will be collected during routine clinical care. Blood samples will also be obtained for metabolomic analysis to identify molecular profiles associated with HFNC success or failure.

The primary objective is to identify metabolomic and clinical predictors associated with HFNC failure and escalation of respiratory support. Secondary objectives include evaluating the association between metabolomic patterns and relevant clinical outcomes such as endotracheal intubation, duration of respiratory support, intensive care unit (ICU) length of stay, and mortality. The study also aims to develop predictive models integrating biological and clinical data to support personalized respiratory management strategies in AHRF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years old).
  • Admission to the intensive care unit (ICU) with acute hypoxemic respiratory failure (AHRF).
  • Treatment with high-flow nasal cannula (HFNC) as the initial respiratory support strategy.
  • Inclusion within the first 24 hours after HFNC initiation.
  • Provision of informed consent by the patient or legally authorized representative.

Exclusion criteria

  • Age <18 years.
  • Active do-not-resuscitate (DNR) orders or limitation of therapeutic effort.
  • Refusal or inability to provide informed consent.
  • Previous invasive mechanical ventilation before study inclusion.

Treatment and study plan

Primary outcomes

  1. HFNC Failure

    Time frame: Within the first 28 days after HFNC initiation.

    Failure of high-flow nasal cannula (HFNC), defined as the need for invasive mechanical ventilation in patients with acute hypoxemic respiratory failure (AHRF).

Secondary outcomes

  1. Predictive Performance of the Metabolomic-Clinical Model

    Time frame: Baseline and within the first 24 hours after HFNC initiation.

    Comparison of the predictive accuracy of the metabolomic-clinical model versus the ROX index for predicting HFNC failure.

Other outcomes

  1. ICU Mortality

    Time frame: Up to ICU discharge or 28 days.

    All-cause mortality during ICU admission.

  2. Duration of Respiratory Support

    Time frame: Up to 28 days.

    Duration of HFNC therapy and invasive mechanical ventilation among patients requiring intubation.

  3. Association Between Metabolomic Profiles and Clinical Phenotypes

    Time frame: Baseline, day 3, and day 5.

    Association between metabolomic biomarkers and clinical phenotypes according to sex, age, and etiology of acute hypoxemic respiratory failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco José Parrilla-Gómez, MD, Phd

CONTACT

[email protected]

+34 747424848

Joan Ramon Masclans Enviz, MD, PhD

CONTACT

[email protected]

+34 639383309

Sponsors and collaborators

Lead sponsor

Hospital del Mar Research Institute (IMIM)

Other

Collaborators

  • Fundació La Marató de TV3
  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospital Universitari de Bellvitge
  • Institute for Bioengineering of Catalonia
  • Instituto de Salud Carlos III
  • Parc Taulí Hospital Universitari

Registry information

Official study title

Metabolomics and Clinical Data to Predict High-Flow Nasal Cannula Failure and Optimize Respiratory Support in Acute Hypoxemic Respiratory Failure

Acronym: META-RESPIRE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 26, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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